FDA 510(k) Applications Submitted by Kevin Mader
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150504 |
02/26/2015 |
GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor |
PCI MEDICAL, INC. |
| K080652 |
03/07/2008 |
MERCURY VCO2 MODULE WITH CAPNOSTAT 5 |
RESPIRONICS NOVAMETRIX LLC |
| K091459 |
05/18/2009 |
PHILIPS NM3 MONITOR, MODEL 7900 |
RESPIRONICS NOVAMETRIX LLC |
| K041450 |
06/01/2004 |
MODIFICATION TO NICO WITH MARS, MODEL 7300 |
RESPIRONICS NOVAMETRIX, INC. |
| K092217 |
07/22/2009 |
MERCURY VCO2 |
RESPIRONICS NOVAMETRIX, INC. |
| K042601 |
09/24/2004 |
CAPNOSTAT 5 |
RESPIRONICS NOVAMETRIX, INC. |
| K053174 |
11/14/2005 |
LOFLO C5 CO2 SENSOR |
RESPIRONICS NOVAMETRIX LLC |
| K163313 |
11/23/2016 |
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K103578 |
12/06/2010 |
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST |
RESPIRONICS NOVAMETRIX, LLC |
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